RASH RELIEF- arnica montana, calendula officinalis, sambucus nigra salve

United States - English - NLM (National Library of Medicine)

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Active ingredient:
EACH DOSE CONTAINS EQUAL PARTS OF, ARNICA MONTANA 1X HPUS (ARNIC), cALENDULA OFFICINALIS 1X HPUS (MARIGOLD), SAMBUCUS NIGRA 1 X (ELDERBERRY)
Available from:
PUREMEDY
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
ITCHY AND BURNING SKIN WOUND HEALING SWELLING, RED BURING SPOTS ON CHEEKS TEMPORARILY RELIEVES SYMPTOMS COMMONLY ASSOCUATED WITH RASHES. PRODUCT USES ARE BASED ON HOMEOPATHIS MATERIA MEDICA. THESE 'USES' HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT HAS NOT BEEN CLINICALLY TESTED BY PUREMEDY INC.
Authorization status:
unapproved homeopathic
Authorization number:
52810-218-11

RASH RELIEF- arnica montana, calendula officinalis, sambucus nigra salve

PUREMEDY

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for

safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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RASH RELIEF

ACTIVE INGREDIENTS

EACH DOSE CONTAINS EQUAL PARTS OF

ARNICA MONTANA 1X HPUS (ARNIC)

cALENDULA OFFICINALIS 1X HPUS (MARIGOLD)

SAMBUCUS NIGRA 1 X (ELDERBERRY)

PURPOSE

ITCHY AND BURNING SKIN

WOUND HEALING

SWELLING, RED BURING SPOTS ON CHEEKS

USES

TEMPORARILY RELIEVES SYMPTOMS COMMONLY ASSOCUATED WITH RASHES.

PRODUCT USES ARE BASED ON HOMEOPATHIS MATERIA MEDICA. THESE 'USES' HAVE

NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT

HAS NOT BEEN CLINICALLY TESTED BY PUREMEDY INC.

DIRECTIONS

TEST FOR ALLERGY BY RUBBING a small amount on skin before use. apply topically to affected

area 2-3 times a day, or as directed by your physician.

INACTIVE INGREDIENTS

CASTOR OIL, HYDROGENATED CASTOR OIL WAX, EXTRA VIRGIN OLIVE OIL

WARNINGS

FOR EXTERNAL USE ONLY. DO NOT USE IF YOU HAVE AN ALLERGY OR

HYPERSENSITIVITY TO THE COMPONENTS OF THE FORMULA OR IF YOU HAVE HAD A

PRIOR REACTION TO THIS SALVE. STOP USE AND ASK A DOCTOR IF SYMPTOMS

PERSISTS OR WORSEN. AVOID CONTACT WITH EYES.

KEEP ALL DRUGS OUT OF REACH OF CHILDREN.

QUESTIONS OR COMMENTS?

CALL 818-851-9014 BETWEEN 8:AM AND 5:PM PST

RASH RELIEF

arnica montana, calendula officinalis, sambucus nigra salve

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:528 10 -218

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CALENDULA O FFICINALIS FLO WER (UNII: P0 M7O4Y7YD) (CALENDULA

OFFICINALIS FLOWER - UNII:P0 M7O4Y7YD)

CALENDULA

OFFICINALIS FLOWER

1 [hp_X]

in 10 0 mL

SAMBUCUS NIGRA FLO WER (UNII: 0 7V4DX0 9 4T) (SAMBUCUS NIGRA FLOWER -

UNII:0 7V4DX0 9 4T)

SAMBUCUS NIGRA

FLOWER

1 [hp_X]

in 10 0 mL

ARNICA MO NTANA (UNII: O8 0 TY20 8 ZW) (ARNICA MONTANA - UNII:O8 0 TY20 8 ZW)

ARNICA MONTANA

1 [hp_X]

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

O LIVE O IL (UNII: 6 UYK2W1W1E)

CASTO R O IL (UNII: D5340 Y2I9 G)

HYDRO GENATED CASTO R O IL (UNII: ZF9 4AP8 MEY)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:528 10 -218 -11

30 mL in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

0 5/0 4/20 15

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 5/0 4/20 15

Labeler -

PUREMEDY (003552251)

Establishment

PUREMEDY

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

PUREMEDY

0 0 3552251

ma nufa c ture (528 10 -218 )

Revised: 4/2020

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